Surgical cassette

ABSTRACT

A surgical cassette for use with a phacoemulsification system having a front plate, a back plate, and a gasket therebetween. The front plate having molded fluid channels that mate with the gasket. The gasket having multiple valves and a sensor or diaphragm accessible through the back plate.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of, and claims priority to, U.S.application Ser. No. 13/776,988, filed on Feb. 26, 2013, which claimspriority to U.S. provisional application No. 61/612,307, entitled“Surgical Cassette”, filed on Mar. 17, 2012, the entire contents ofwhich are hereby incorporated by reference in their entirety for allpurposes as if fully set forth herein.

TECHNICAL FIELD OF THE INVENTION

The present invention is generally related to methods, devices, andsystems for controlling surgical fluid flows, particularly duringtreatment of an eye.

BACKGROUND OF THE INVENTION

The optical elements of the eye include both a cornea (at the front ofthe eye) and a lens within the eye. The lens and cornea work together tofocus light onto the retina at the back of the eye. The lens alsochanges in shape, adjusting the focus of the eye to vary between viewingnear objects and far objects. The lens is found just behind the pupil,and within a capsular bag. This capsular bag is a thin, relativelydelicate structure which separates the eye into anterior and posteriorchambers.

With age, clouding of the lens or cataracts are fairly common. Cataractsmay form in the hard central nucleus of the lens, in the softerperipheral cortical portion of the lens, or at the back of the lens nearthe capsular bag.

Cataracts can be treated by the replacement of the cloudy lens with anartificial lens. Phacoemulsification systems often use ultrasound energyto fragment the lens and aspirate the lens material from within thecapsular bag. This may allow the capsular bag to be used for positioningof the artificial lens, and maintains the separation between theanterior portion of the eye and the vitreous humour in the posteriorchamber of the eye.

During cataract surgery and other therapies of the eye, accurate controlover the volume of fluid within the eye is highly beneficial. Forexample, while ultrasound energy breaks up the lens and allows it to bedrawn into a treatment probe with an aspiration flow, a correspondingirrigation flow may be introduced into the eye so that the total volumeof fluid in the eye does not change excessively. If the total volume offluid in the eye is allowed to get too low at any time during theprocedure, the eye may collapse and cause significant tissue damage.Similarly, excessive pressure within the eye may strain and injuretissues of the eye.

While a variety of specific fluid transport mechanisms have been used inphacoemulsification and other treatment systems for the eyes, aspirationflow systems can generally be classified in two categories: 1)volumetric-based aspiration flow systems using positive displacementpumps; and 2) vacuum-based aspiration systems using a vacuum source,typically applied to the aspiration flow through an air-liquidinterface. These two categories of aspiration flow systems each haveunique characteristics that render one more suitable for some proceduresthan the other, and vice versa.

Among positive displacement aspiration systems, peristaltic pumps (whichuse rotating rollers that press against a flexible tubing to induceflow) are commonly employed. Such pumps provide accurate control overthe flow volume. The pressure of the flow, however, is less accuratelycontrolled and the variations in vacuum may result in the feel ortraction of the handpiece varying during a procedure. Peristaltic andother displacement pump systems may also be somewhat slow.

Vacuum-based aspiration systems provide accurate control over the fluidpressure within the eye, particularly when combined with gravity-fedirrigation systems. While vacuum-based systems can result in excessivefluid flows in some circumstances, they provide advantages, for example,when removing a relatively large quantity of the viscous vitreous humourfrom the posterior chamber of the eye. However, Venturi pumps and othervacuum-based aspiration flow systems are subject to pressure surgesduring occlusion of the treatment probe, and such pressure surges maydecrease the surgeon's control over the eye treatment procedure.

Different tissues may be aspirated from the anterior chamber of the eyewith the two different types of aspiration flow. For example,vacuum-induced aspiration flow may quickly aspirate tissues at asignificant distance from a delicate structure of the eye (such as thecapsular bag), while tissues that are closer to the capsular bag areaspirated more methodically using displacement-induced flows.

Conventionally, fluid aspiration systems include a console and a fluidiccassette mounted on the console. The fluidic cassette is typicallychanged for each patient and cooperates with the console to providefluid aspiration. Generally, a single type of cassette is used by aparticular console, regardless of whether the procedure will requirepositive displacement aspiration, vacuum-based aspiration, or both. U.S.Pat. No. 8,070,712; U.S. Published Application 2008011431; and U.S.Published Application 20080114291 provide examples of cassettescurrently used in the marketplace, the contents of each are herewithincorporated by reference in their entirety as if set forth herein.

In light of the above, it would be advantageous to provide improveddevices, systems, and methods for eye surgery.

SUMMARY OF THE INVENTION

The present invention provides a surgical cassette having a front plate,a back plate, and a gasket, wherein at least a portion of the gasket islocated between the front plate and the back plate. The gasket may alsohave one or more valves and a sensor; and the one or more valves and thesensor are accessible through the back plate. The surgical cassette mayalso have one or more tube retainers configured and dimensioned to guidea portion of a tube into a desired shape. The desired shape may becapable of being used with a peristaltic pump. The tube retainers may beconfigured and dimensioned to constrain the tube to prevent axial ortorsional movement of the tube.

The present invention also provides a surgical system having a console,a handpiece, and a cassette, wherein the cassette couples the handpiecewith the console. The cassette may have a front plate, a back plate, anda gasket, wherein at least a portion of the gasket is located betweenthe front plate and the back plate. The gasket may have one or morevalves and a sensor; and the one or more valves and the sensor may beaccessible through the back plate.

The present invention also provides a surgical cassette having a frontplate having a top portion, a bottom portion, and a front surface,wherein the front plate comprises a handle and thumb shield locatedbetween the top portion and the bottom on the front surface. The thumbshield may be located above the handle and comprises a first surface,wherein the first surface comprises a horizontally extending raisedsurface to constrain a thumb from extending above the top portion.

The present invention also provides a surgical cassette having asurface, wherein the surface comprises one or more raised surfaceshaving a substantially circular shape and wherein the one or more raisedsurfaces are configured and dimensioned to provide at least one highpoint for coupling with an engagement mechanism. The engagementmechanism may be selected from the group consisting of a positionmechanism and a clamping mechanism. The position mechanism may beselected from the group consisting of a linear actuator, a rotaryactuator, and a magnetic coupling. The clamping mechanism may beselected from the group consisting of an electrical actuator, ahydraulic actuator, and pneumatic actuator.

The present invention also provides a gasket having a body, wherein thebody is deformable and has a front surface and a back surface. The frontsurface may have one or more raised contours that create one or morechannel that are configured and dimensioned to control fluid flowthrough one or more corresponding channels of a surgical cassette. Theback surface may have one or more elevated portions that correspond tothe one or more channels of the front surface and act as a valve. Thegasket may also have a deformable membrane having an annular surfacecapable of coupling with a transducer of a surgical console.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is best understood with reference to the followingdetailed description of the invention and the drawings in which:

FIG. 1 schematically illustrates an eye treatment system in which acassette couples an eye treatment probe with an eye treatment console;

FIG. 2 illustrates an exemplary surgical cassette having a surgicalfluid pathway network for use in the system of FIG. 1;

FIG. 3 is a perspective view of an exemplary drain bag port;

FIG. 4a is a back view of an exemplary surgical cassette;

FIG. 4b is a perspective back view of an exemplary surgical cassette;

FIG. 4c is a perspective back view of an exemplary surgical cassette;

FIG. 5a is an exploded view of an exemplary surgical cassette;

FIG. 5b is a top view of the back of the front plate of an exemplarysurgical cassette;

FIG. 6 is an exploded view of an exemplary surgical cassette;

FIG. 7 is an exploded view of an exemplary surgical cassette;

FIG. 8 is a perspective view of the front of an exemplary surgicalcassette;

FIG. 9a is a perspective view of the front of an exemplary surgicalcassette with a drain bag;

FIG. 9b is a perspective view of the back of an exemplary surgicalcassette with a drain bag and flexible conduit;

FIG. 10a is a perspective view of the back of an exemplary gasket;

FIG. 10b is a perspective view of the front of an exemplary gasket;

FIG. 11 is a top view of an exemplary surgical console;

FIG. 11a is a perspective view of the front of an exemplary surgicalconsole;

FIG. 12 is a top view of an exemplary surgical console with a surgicalcassette coupled therewith;

FIG. 13 is a perspective view of an exemplary surgical console with asurgical cassette coupled therewith;

FIG. 14a is a cross-sectional view of an exemplary surgical cassetteclamping mechanism;

FIG. 14b detailed view of the exemplary surgical cassette interface(part A) as illustrated in FIG. 14 a;

FIG. 15a is a perspective view of an exemplary surgical cassette clamp;

FIG. 15b is a perspective view of an exemplary surgical cassette clamp;

FIG. 16a is a cross-sectional view of an exemplary surgical cassettedetection mechanism;

FIG. 16b is a cross-sectional view of an exemplary surgical cassettedetection mechanism;

FIG. 17a is a cross-section view of an exemplary peristaltic pump rollerassembly;

FIG. 17b is a detailed view of the exemplary peristaltic pump rollerassembly (part B) as illustrated in FIG. 17a ; and

FIG. 18 is a cross-sectional view of an exemplary surgical cassetteillustrating the peristaltic pump tube and peristaltic pump profile.

DETAILED DESCRIPTION OF THE INVENTION

Reference will now be made in detail to embodiments of the invention,examples of which are illustrated in the accompanying drawings. Whilethe invention will be described in conjunction with the embodiments, itwill be understood that they are not intended to limit the invention tothose embodiments. On the contrary, the invention is intended to coveralternatives, modifications, and equivalents, which may be includedwithin the spirit and scope of the invention as defined by the appendedclaims.

Referring to FIG. 1, a system 10 for treating an eye E of a patient Pgenerally includes an eye treatment probe handpiece 12 coupled to aconsole 14 by a cassette 100 mounted on the console. Handpiece 12 mayinclude a handle for manually manipulating and supporting an insertableprobe tip. The probe tip has a distal end which is insertable into theeye, with one or more lumens in the probe tip allowing irrigation fluidto flow from the console 14 and/or cassette 100 into the eye. Aspirationfluid may also be withdrawn through a lumen of the probe tip, with theconsole 14 and cassette 100 generally including a vacuum aspirationsource, a positive displacement aspiration pump, or both to helpwithdraw and control a flow of surgical fluids into and out of eye E. Asthe surgical fluids may include biological materials that should not betransferred between patients, cassette 100 will often comprise adisposable (or alternatively, sterilizable) structure, with the surgicalfluids being transmitted through flexible conduits 18 of the cassettethat avoid direct contact in between those fluids and the components ofconsole 14.

When a distal end of the probe tip of handpiece 12 is inserted into aneye E, for example, for removal of a lens of a patient with cataracts,an electrical conductor and/or pneumatic line (not shown) may supplyenergy from console 14 to an ultrasound transmitter of the handpiece, acutter mechanism, or the like. Alternatively, the handpiece 12 may beconfigured as an irrigation/aspiration (I/A) or vitrectomy handpiece.Also, the ultrasonic transmitter may be replaced by other means foremulsifying a lens, such as a high energy laser beam. The ultrasoundenergy from handpiece 12 helps to fragment the tissue of the lens, whichcan then be drawn into a port of the tip by aspiration flow. So as tobalance the volume of material removed by the aspiration flow, anirrigation flow through handpiece 12 (or a separate probe structure) mayalso be provided, with both the aspiration and irrigations flows beingcontrolled by console 14.

So as to avoid cross-contamination between patients without incurringexcessive expenditures for each procedure, cassette 100 and its flexibleconduit 18 may be disposable. Alternatively, the flexible conduit ortubing may be disposable, with the cassette body and/or other structuresof the cassette being sterilizable. Regardless, the disposablecomponents of the cassette are typically configured for use with asingle patient, and may not be suitable for sterilization. The cassettewill interface with reusable (and often quite expensive) components ofconsole 14, which may include one or more peristaltic pump rollers, aVenturi or other vacuum source, a controller 40, and the like.

Controller 40 may include an embedded microcontroller and/or many of thecomponents common to a personal computer, such as a processor, data bus,a memory, input and/or output devices (including a touch screen userinterface 42), and the like. Controller 40 will often include bothhardware and software, with the software typically comprising machinereadable code or programming instructions for implementing one, some, orall of the methods described herein. The code may be embodied by atangible media such as a memory, a magnetic recording media, an opticalrecording media, or the like. Controller 40 may have (or be coupled to)a recording media reader, or the code may be transmitted to controller40 by a network connection such as an internet, an intranet, anEthernet, a wireless network, or the like. Along with programming code,controller 40 may include stored data for implementing the methodsdescribed herein, and may generate and/or store data that recordsperimeters with corresponding to the treatment of one or more patients.Many components of console 14 may be found in or modified from knowncommercial phacoemulsification systems from Abbott Medical Optics Inc.of Santa Ana, Calif.; Alcon Manufacturing, Ltd. of Ft. Worth, Tex.;Bausch and Lomb of Rochester, N.Y.; and other suppliers.

FIG. 2 illustrates a surgical cassette of the present invention,including components of surgical cassette 100. Surgical cassette 100 isan assembly of fluid pathways and connected tubing configured to manageone or more of the following: fluid inflow, fluid outflow, fluid vacuumlevel, and fluid pressure in a patient's eye E when coupled with console14. Surgical cassette 100 may include grip loop handle 101, whichprovides a sterile means for holding and positioning surgical cassette100 under finger grip control. In an embodiment, grip loop handle 101 isdesigned for an index finger to pass completely thru the loop of thehandle. The grip loop handle 101 may also be designed for the pad of thethumb to rest on outer top surface of grip loop handle 101.

In an embodiment, surgical cassette 100 may include a thumb shield 102.As illustrated in FIG. 2, thumb shield 102 may have a raised borderabove grip loop handle 101, which is configured and dimensioned tosurround a sterile gloved thumb to reduce potential for contact withnon-sterile surfaces during insertion of surgical cassette 100 intoconsole. Thumb shield 102 may have one or more surface elements. Forexample, thumb shield 102 may have one or more generally horizontallyextending raised surfaces to constrain the tip of the thumb fromextending beyond the upper shielded coverage of the frame of surgicalcassette 100. Thumb shield 102 may have in the alternative or inaddition to the one or more horizontally extending raised surface, oneor more generally vertically extending raised surfaces to constrain theside of the thumb from slipping sideways (left or right) beyond thecoverage of the thumb shield 102 constraining surface(s).

In an embodiment, surgical cassette 100 may include drain bag port 103.As illustrated in FIG. 2, drain bag port 103 is an axially extendingcylindrical port with a central opening to enable the transfer of fluidfrom the inside of the surgical cassette 100 manifold to an externallyattached collection reservoir such as drain bag or collection vessel 140(see FIGS. 9a and 9b ). In an embodiment as illustrated in FIG. 3, drainbag port 103 may have one or more recessed notches 103 a in the end faceof drain bag port 103 to provide one or more gaps for fluid to flow intoan externally attached bag. Such a feature helps to minimize thepotential for the bag surface to obstruct fluid outflow through theport. Inside surface feature 103 b may be configured to accept a maleslip luer fitting to support the connection to external tubing sets.

As illustrated in FIG. 2, surgical cassette 100 may include a drain baghook 104. Drain bag hook 104 is a mechanical feature extending outwardfrom the surface of surgical cassette 104 and is configured to interfacewith a corresponding slot feature in the drain bag 140 (see FIG. 9a ) tosupport the weight of the drain bag as it collects fluid.

Surgical cassette 100 may also include one or more clamping domes 106.As illustrated in FIG. 2, clamping domes 106 may be a raised pattern ofspherical domed surfaces with a single high-point to provide lowfriction wiping contact surfaces during loading and concentrate axialclamping forces in specific zones after loading surgical cassette 100with console 14. It is also envisioned that the one or more clampingdomes 106 may be of any shape or size suitable for its function ordesired aesthetic look and feel.

In an embodiment, surgical cassette 100 may include peristaltic pumptube 107. FIG. 4a shows the backside of surgical cassette andperistaltic pump tube 107. Peristaltic pump tube 107 may be anelastomeric length of tubing that is configured to generate positivedisplacement of fluid flow in the direction of pump roller (not shown)when a portion of the tubing is compressed between the peristaltic pumprollers of console 14 and the backing plate pump profile 108 of thesurgical cassette 100. It is also envisioned that any type of flow-basedpump and corresponding components may be used with surgical cassette100. In an embodiment, backing plate pump profile 108 may be comprisedof contoured surfaces formed on the inside of cassette frame/front plate100 a to provide a compressing tubing while creating peristaltic pumpingflow.

As illustrated in FIGS. 4a, 4b, and 4c , surgical cassette 100 may haveaxial mating plane surfaces 105. Axial mating plane surfaces 105 areouter border faces of cassette frame/front plate 100 a that form asurface mating with console 14 within cassette receiver 123 afterloading.

In an embodiment, surgical cassette 100 may also include one or moreperistaltic tube form retainers 109. (See FIGS. 4a, 4b, 4c , 5, 6, and18) Clamping surfaces formed between the cassette frame/front plate 100a and backing plate 100 b are configured to axially retain the tubing tomaintain consistency of tubing stretch and provide centering of tubingwithin peristaltic pump profile 108. Form retainers 109 may comprisemating sections 109 a of cassette frame front plate 100 a. Formretainers 109 are configured and dimensioned to shape peristaltic pumptube 107 and in the embodiment illustrated in the figures, to guideperistaltic pump tube 107 into an approximately 180 degree turn on eachend of tube 107.

In an embodiment as illustrated in FIGS. 4a, 4b, and 4c , backing plate100 b may be recessed within cassette frame/front plate 100 a such thatwhen surgical cassette 100 is inserted into console 14, backing plate100 b does not touch the cassette receiver 123. In the alternative,backing plate 100 b may be configured and dimensioned to touch cassettereceiver 123.

Referring to FIGS. 5a, 5b , 6, 7, and 18, surgical cassette 100 may alsoinclude one or more pump tube interface ports 110. Pump tube interfaceports 110 are inlet and outlet transition ports to transition fluid flowfrom internal molded manifold fluid flow channels 111 to peristalticpump tube 107. In an embodiment, surgical cassette 100 may also includeone or more manifold fluid flow channels 111. Manifold fluid flowchannels 111 are fluid flow pathways formed as raised surfaces allowingfluid to flow in internal channels between the raised surfaces and outerperimeter sealing border of gasket 120 to retain fluid within themanifold fluid flow channels 111 under positive pressure and vacuumconditions. Manifold fluid flow channels 111 may comprise irrigationflow channel 111 a, which is a pathway with an inlet tubing port frombalance salt solution (BSS) irrigation bottle metered by valves to oneor more, preferably two outlet ports: (1) irrigation tubing outlet port118 connected to an external surgical handpiece 12 flowing fluid to theeye, which may be metered or controlled by irrigation valve 113; and (2)venting line 111 b providing BSS irrigation fluid into an aspirationline of flexible conduits 18 which may be metered or controlled by ventvalve 114.

Manifold fluid flow channels 111 may also have aspiration flow channel111 b. Aspiration flow channel 111 b may include a pressure/vacuumsensor element 111 c, a pumping outlet port 111 d, and two inlet portscomprising aspiration fluid inflow from tubing line connected toexternal surgical handpiece 12 and venting fluid inflow from BSSirrigation bottle, which may be metered by vent valve 114. Manifoldfluid flow channels 111 may also comprise vent flow channel 111 c. Ventflow channel 111 c is a pathway configured to provide BSS irrigationfluid into the aspiration line, which may be metered by vent valve 114to reduce vacuum level in the aspiration line following handpiece 12 tipobstruction or occlusion. Manifold fluid flow channels 111 may also havemanifold channel sealing surfaces 112, which comprise the top surface orportion thereof of the channels 111.

Referring to FIGS. 4a, 4b, 4c , 5, and 6, surgical cassette 100 mayinclude irrigation valve 113, which in an embodiment may have adome-like shape. Irrigation valve 113 may be an elastomeric deformablesurface which allows irrigation flow from a BSS bottle to externalsurgical handpiece 12 when uncompressed and shuts off flow when deformedinwards towards manifold fluid flow channels 111. Surgical cassette 100may also include vent valve 114, which in an embodiment may have adome-like shape. Vent valve 114 may be an elastomeric deformable surfacewhich allows irrigation flow from the BSS bottle through the aspirationline that coupled with the external surgical handpiece 12 resulting invacuum level reduction when uncompressed and shuts off flow whendeformed inwards towards manifold fluid flow channels 111. The level offluid flow may be controlled based upon the level of compression ofvalves (113 and 114)—from full flow to intermediate flow to no flow.

In an embodiment illustrated in FIGS. 5a, 5b , and 6, surgical cassette100 may have irrigation valve control surface 115. Irrigation valvecontrol surface 115 may be a raised sealing surface in manifold fluidflow channels 111 that provides irrigation fluid flow reduction orshutoff from the BSS irrigation bottle to an irrigation inlet fitting ofsurgical handpiece 12 when irrigation valve control dome is compressedor activated. Surgical handpiece 100 may also include vent valve controlsurface 116. Vent valve control surface 116 may be a raised sealingsurface in manifold fluid flow channels 111 that provides shutoff ofventing of irrigation fluid flow from the BSS irrigation bottle to anaspiration fitting of surgical handpiece 12 when vent valve 114 iscompressed or activated.

In an embodiment illustrated in FIG. 8, surgical cassette 100 mayinclude irrigation inlet tubing port 117, irrigation outlet tubing port118, and aspiration outlet tubing port 119. Irrigation inlet tubing port117 may be a connection port for tubing extending to the BSS irrigationbottle to deliver irrigation fluid to manifold fluid flow channels 111.Irrigation outlet tubing port 118 may be a connection port for tubingextending to the surgical handpiece 12 irrigation fitting to deliverirrigation fluid from manifold fluid flow channels 111 to patient's eyeE. Aspiration outlet tubing port 119 may be a connection port for tubingextending to the surgical handpiece 12 aspiration fitting for removingfluid from a patient's eye E by means of a pump, such as a flow-basedpump, preferably a peristaltic pump comprising the peristaltic pump tube107. In an embodiment, surgical cassette 100 may also include or in thealternative of drain bag port 103, optional drain port 103 c, which maybe connected to an external tubing line or reservoir. In an embodiment,drain port 103 c may be closed by a plug or similar device known in theart.

Surgical cassette 100 may include gasket 120 as illustrated in FIGS. 10aand 10b , which may be an integrated elastomeric fluid channel sealinggasket. Gasket 120 may include a vacuum/pressure sensor diaphragm 120 a,irrigation valve control dome 113, and vent valve control dome 114.Gasket 120 may also include fluid channel sealing surfaces 120 b.Vacuum/pressure sensor diaphragm 120 a may be a sealed flexible annularmembrane with a central magnetic coupling disk which deforms: (1)proportionally outwards under fluid pressure conditions compressing amagnetically-coupled force displacement transducer of console 14allowing for non-fluid contact measurement of fluid pressure levelinside the aspiration fluid pathways of surgical cassette 100; and (2)proportionally inwards under fluid vacuum conditions extending themagnetically-coupled force displacement transducer of console 14allowing for non-fluid contact measurement of fluid vacuum level insidethe aspiration fluid pathways of surgical cassette 100. In anembodiment, gasket 120 may have one or more fluid channel sealingsurfaces 120 b, which may be a raised lip portion of the gasket 120. Inthe embodiment shown in FIG. 10a , two such sealing surfaces 120 b areillustrated.

In an embodiment, gasket 120 may be molded onto the backing plate 100 bby co-molding or any other process known in the art. Co-molding thegasket 120 and backing plate 100 b result in a combination ofelastomeric features of gasket 120 and rigid features of backing plate100 b.

In an embodiment, surgical cassette 100 may also include pressure/vacuumsensor concentric alignment ring 121 as illustrated in FIGS. 4a, 4b, 4c,and 5a . Alignment ring 121 may include a pattern of a radially orientedrib features defining a circular arc of a specific diameter and locationto provide for concentric alignment between the center of themagnetically-coupled force displacement transducer 131 of console 14 andthe center of vacuum/pressure diaphragm 120 a of surgical cassette 100.The pattern may comprise one or more radially oriented rib features,preferably a minimum of three radially oriented rib features.

In FIGS. 11, 11 a, 12 and 13, fluidics module 122 is illustratedaccording to an embodiment of the present invention. Fluidics module 122comprises an assembly of components mounted in console 14 forinterfacing with surgical cassette 100. Fluidics module 122 may have oneor more of the components described herein. Fluidics module 122 may havecassette receiver 123, cassette pre-load detection pin 124, and pre-loaddetection switch 125 (shown in FIG. 16a ). Cassette receiver 123 may bea section of fluidics module 122 defining an engagement area for loadingand aligning surgical cassette 100 in its intended position relative tovarious components of fluidics module 122. Cassette receiver 123 mayhave tapered lead-in pre-alignment surfaces 123 a, which may includeoutside vertical and horizontal border surfaces of cassette receiver 123that may be tapered towards the center of the opening of cassettereceiver 123 to guide surgical cassette 100 into a substantiallycentered position during off-angle insertion. Cassette receiver 123 mayalso have axial interface surface 123 b, which may include planarengagement surfaces where cassette frame/front plate 100 a bottoms outwhen fully constrained by rotary clamps 126, 127.

Cassette pre-load detection pin 124 may be a spring-loaded pin displacedrearwards when surgical cassette 100 is initially inserted with an endor side surface triggering a switch and initiating closure of rotaryclamps 126, 127. Pre-load detection switch 125 may be a switch componentthat changes electrical output state when cassette pre-load detectionpin 124 has been displaced to a specific axial position indicatingsurgical cassette 100 is in an appropriate position for loadingengagement by rotary clamps 126, 127 (see FIGS. 15a and 15b ). In anoptional embodiment, as shown in FIG. 16b , a second detection switch142 may be located next to or behind detection switch 125 to monitor theposition of pre-load detection pin 124 to verify that surgical cassette100 reaches its intended interface position at the completion of thecassette clamping mechanism closure.

Left rotary clamp 126 may be a rotating clamping component configuredwith specific surfaces to clamp surgical cassette 100 when rotated in acounter-clockwise direction as viewed from the top T and specificejection surfaces to disengage surgical cassette 100 when rotated in theopposite direction. Right rotary clamp 127 may be a rotating clampingcomponent configured with specific surfaces to clamp surgical cassette100 when rotated in a clockwise direction as viewed from top T andspecific ejection surfaces to disengage surgical cassette 100 whenrotated in the opposite direction.

In an embodiment, fluidics module 122 may have a left clamping motoractuator 128 and a right clamping motor actuator 129. Left clampingmotor actuator 128 may be a reversible rotary actuator powered byelectricity, pneumatics, hydraulics, or any other means know in the art,that controls the rotational position of the left rotary clamp 126 toalternately load and eject surgical cassette 100. Right clamping motoractuator 129 may be a reversible rotary actuator powered by electricity,pneumatics, hydraulics, or any other means know in the art, thatcontrols the rotational position of the right rotary clamp 127 toalternately load and eject surgical cassette 100. The actuation of themotor actuators 128 and 129 may be simultaneously or individuallycontrolled.

In an embodiment, fluidics module 122 may have a pump roller assembly130. Pump roller assembly may have a configuration of multiple rollerelements in a circular or substantially circular pattern which produceperistaltic flow-based fluid transport when rotated against compressedfluid-filled peristaltic pump tube 107.

In an embodiment, fluidics module 122 may have a force displacementtransducer 131. Force displacement transducer 131 may operate by meansof a magnetic coupling, such that fluid vacuum inside manifold fluidflow channels 111 causes deformation inwards of vacuum/pressure sensordiaphragm 120 a in surgical cassette 100, which axially extends forcedisplacement transducer 131 resulting in a change of an electricaloutput signal in proportion to a vacuum level. Positive fluid pressurein manifold fluid flow channels 111 results in an outward extension ofvacuum/pressure sensor diaphragm 120 a and compression of the forcedisplacement transducer 131.

In an embodiment, fluidics module 122 may have irrigation valve plunger132 and vent valve plunger 133. Irrigation valve plunger 132 may have anaxial extension of the plunger that compresses irrigation valve 113 ofsurgical cassette 100 resulting in a decrease or shutoff of irrigationflow to external irrigation tubing line of flexible conduit 18.Irrigation valve plunger 132 may also operate by a spring-loadedretraction of the plunger to allow varying levels of irrigation flow.Vent valve plunger 133 may have an axial extension of the plunger thatcompresses vent valve 114 of surgical cassette 100 resulting in adecrease or shutoff of irrigation venting flow to external aspirationtubing line of flexible conduit 18. Vent valve plunger 133 may alsooperate by a spring-loaded retraction of the plunger to allow irrigationpressure fluid flow to vent vacuum level in aspiration tubing line offlexible conduit 18.

In an embodiment, fluidics module 122 may have one or more of thefollowing components: peristaltic drive motor actuator 134, peristalticpump motor drive pulley 135, peristaltic drive belt 136, peristalticroller driven pulley 137, and pump roller guide bearings 138.Peristaltic drive motor actuator 134 may be a reversible rotary actuatorpowered by electricity, pneumatics, hydraulics, or any other means knownin the art that controls the rotational position of the peristaltic pumproller assembly 130. Peristaltic pump motor drive pulley 135 may have apulley wheel connected to the rotary drive shaft of peristaltic drivemotor actuator 134 to provide a mating interface for peristaltic drivebelt 136 when peristaltic drive motor actuator 134 is oriented on anoffset parallel axis to peristaltic pump roller assembly 130 forreducing overall height of fluidics module 122. Peristaltic rollerdriven pulley 137 may have a pulley wheel connected to rotary shaftperistaltic pump roller assembly 130. Peristaltic drive belt 136 may bea belt connecting peristaltic pump motor drive pulley 135 to peristalticroller driven pulley 137 to transfer rotation of the pump drive motorshaft to the peristaltic pump roller assembly 130.

Pump roller guide bearings 138 may have at least one low frictionbearing placed in concentric alignment with peristaltic pump rollerassembly 130 to guide shaft rotation of peristaltic pump roller assembly130. Pump roller guide bearings 138 may compensate for off-axis forcesfrom compression of peristaltic pump tube 107 by peristaltic pump rollerassembly 130 and peristaltic drive belt 136 tension between pulleys 135and 137.

In an embodiment, fluidics module 122 may have rotary pump rollerposition encoder 139. Rotary pump roller position encoder may have anelectronic output signal indicating rotary position of peristaltic pumproller assembly 130, which may be used to derive and confirm intendedrotational speed during peristaltic pumping. Rotary pump roller positionencoder 139 may also be used to provide controlled rotary positionchanges for the following purposes: increase or decrease pressure levelin fluid line by a target amount by transferring a pre-determined volumeof fluid into or out of the fluid line faster than closed-loop pressuremonitoring allows based on an algorithm assuming a known overall systemvolume; and/or increase or decrease vacuum level in fluid line by atarget amount by transferring a pre-determined volume of fluid into orout of fluid line faster than closed-loop vacuum monitoring allows basedon an algorithm assuming a known overall system volume.

Operation of Surgical Cassette and Console

The following describes an example of operating surgical cassette 100and console 14 according to an embodiment of the present invention. Asurgical technician grasps surgical cassette 100 by placing an indexfinger through the opening of grip loop handle 101 and gripping handle101 with thumb pressure on thumb shield 102 (outer top surface ofhandle). The surgical technician's hand can remain sterile while tubinglines are handed off to supporting non-sterile staff to make connectionsto the non-sterile BSS irrigation bottle. With the surgical technician'sthumb being shielded from inadvertent contact with non-sterile outersurfaces of console 14 by means of thumb shield 102, surgical cassette100 may be directly inserted into cassette receiver 123 of fluidicsmodule 122 with centering guidance provided by tapered outer surfaces123 a. The direct axial insertion of surgical cassette 100 into cassettereceiver 123 of fluidics module 122 results in axial mating planesurfaces 105 contacting ejection surfaces 126 b and 127 b of left andright rotary clamps 126,127. (See FIGS. 14a, 14b, 15a, and 15b ).

Approximately synchronized with contacting ejection surfaces 126 b and127 b of rotary clamps 126, 127, cassette pre-load detection pin 124 iscompressed triggering a switch signal to be sent from cassette pre-loaddetection switch 125 to the control means of console 14. Triggering ofcassette pre-load detection switch 125, triggers rotation of clampingmotor actuators 128, 129 and contact between loading clamp surfaces 126a, 127 a of rotary clamps 126, 127 and clamping domes 106 on cassetteframe/front plate 100 a. Clamping motor actuators 128, 129 will continueto rotate until axial mating plane surfaces 105 of cassette frame/frontplate 100 a are compressed fully flat and parallel to mounting referencesurfaces of fluidic module 122.

Surgical cassette 100 is guided into horizontal and vertical preferredalignment by concentric alignment of ribs 121 of pressure/vacuum sensordiaphragm 120 a of surgical cassette 100 with outer ring surface 131 a(see FIG. 11a ) of force displacement transducer 131. See FIG. 11a .After tubing connections are made to external accessories (e.g.,handpiece 12 with attached phaco needle tip and irrigation sleeve (notshown)), surgical staff initiates a fluid priming of tubing lines andinternal cassette fluid pathways (i.e. manifold fluid flow channels 111)with irrigation fluid delivered from an irrigation source (e.g. BSSbottle)

Console 14 may verify one or more of the following: proper tubingconnections, fluid line sealing, and fluid control operation during thepriming procedure by generating flow through aspiration pathways ofmanifold fluid flow channels 111 by rotating peristaltic pump rollerassembly 130 against outer surface of peristaltic pump tube 107 incompression against peristaltic pump profile 108 of backing plate 100 b.

Desired and/or appropriate pressure and vacuum levels are verified bymeans of the magnetically-coupled pressure/vacuum sensor diaphragm 120pulling outwards on force displacement transducer 131 in proportion toan actual vacuum level and pushing inwards in proportion to actualpressure levels.

Fluid flow may be metered on and off or varied by means of extending andretracting irrigation and vent valve plungers 132, 133, which shutoff orvary fluid flow when extended to compress sealing surfaces of irrigationvalve 113 and vent valve 114 against irrigation and vent valve surfaces115, 116.

A surgical user may control the outflow rate of fluid from externallyattached tubing accessories (e.g., handpiece 12 with attached phaco tipand irrigation sleeve (not shown)) by selecting desired aspiration pumpflow rate which is converted by one or more control algorithms ofconsole 14 into speed of rotation of peristaltic pump roller assembly130.

According to an embodiment, to enable reduced overall height of fluidicsmodule 122, peristaltic drive motor actuator 134 may be configured as aparallel axis drive mechanism such as the belt drive and pulleymechanism described herein. In another embodiment, peristaltic drivemotor actuator 134 may be oriented such that the drive shaft isperpendicular to the peristaltic pump roller assembly 130 using one ormore gears to couple the peristaltic drive motor actuator 134 with theperistaltic pump roller assembly 130. This in turn would also enable areduction of overall height of fluidics module 122.

Referring to FIGS. 16a, 16b, 17a, and 17b , in another embodiment, usinga non-axial drive connection between peristaltic drive motor actuator134 and peristaltic pump roller assembly 130, a rotary pump rollerposition encoder 139, which may be any type of indicator known in theart, may be mounted onto the rotating shaft of peristaltic pump rollerassembly 130 to detect slippage or asynchronous rotation of peristalticdrive motor actuator 134 with respect to peristaltic pump rollerassembly 130. Since peristaltic pumping is generated in directproportion to peristaltic pump roller assembly 130 to rotational speedof peristaltic drive motor actuator 134 during slippage conditions,placement of rotary pump roller position encoder 139 onto peristalticpump roller assembly 130 provides increased accuracy and reliability ofintended operation.

When the surgical procedure is completed, surgical staff initiateejection of surgical cassette 100 from fluidics module 122 by activatingejection switch 141 (see FIG. 11a ) which signals the clamp motoractuators 128, 129 to reverse rotation and disengage axial mating planesurfaces 105 of surgical cassette 100 from axial interface surface 123 bof fluidics module 122 by a controlled distance.

In an embodiment, the final ejected position of surgical cassette 100results in surgical cassette 100 still being retained on its outerborder edges within the lead-in portion 123 a (see FIGS. 11 and 11 a) ofcassette receiver 123 to prevent surgical cassette 100 having internalsurgical waste fluid from falling onto the floor.

All references cited herein are hereby incorporated by reference intheir entirety including any references cited therein.

Although the present invention has been described in terms of specificembodiments, changes and modifications can be carried out withoutdeparting from the scope of the invention which is intended to belimited only by the scope of the claims.

The invention claimed is:
 1. A gasket, comprising: a body, wherein thebody is deformable and has a first side and a second side, wherein thefirst side comprises a raised contour that creates a channel that isconfigured and dimensioned to control fluid flow through a correspondingchannel of a surgical cassette, and wherein the second side comprises anelevated portion that corresponds to the channel of the first side andacts as a valve for fluid flow via the channel created by the contour ofthe first side.
 2. The gasket of claim 1, further comprising adeformable membrane having an annular surface capable of coupling with atransducer of a surgical console.
 3. The gasket of claim 1, wherein theelevated portion comprises a control dome.
 4. The gasket of claim 1,further comprising a vacuum/pressure sensor diaphragm.
 5. The gasket ofclaim 1, wherein the channel of the first side controls fluid flow basedon contact with the corresponding channel of the surgical cassette. 6.The gasket of claim 1, wherein the channel of the first side controlsfluid flow via contact with the fluid such that the fluid is retainedwithin the corresponding channel of the surgical cassette.
 7. The gasketof claim 1, wherein there are a plurality of the raised contours.
 8. Thegasket of claim 1, wherein the raised contour creates a plurality of thechannels that are configured and dimensioned to control fluid flowthrough a plurality of corresponding channels of the surgical cassette.9. The gasket of claim 1, wherein there are a plurality of the elevatedportions that correspond to the channels of the first side.